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Alimera Sciences receives OTC marketing approval for allergy solution

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ATLANTA — The Food and Drug Administration has granted Alimera Sciences Inc. approval to market its ketotifen fumarate solution as an over-the-counter treatment for ocular irritation due to allergies, the company announced.

Alaway (ketotifen fumarate ophthalmic solution 0.025%) is Alimera's first new drug application (NDA) submission and the first to gain approval. Alimera submitted the prescription-to-OTC NDA for Alaway after completing a clinical study showing it to be bioequivalent to Novartis' Zaditor (ketotifen fumarate ophthalmic solution 0.025%), according to a press release from Alimera.

Alaway, to be distributed in 10 mL bottles, is expected to be available by Spring 2007, according to the release.